Circulation set for temperature-controlled catheter and method of using the same

ABSTRACT

The invention provides a single-use, disposable circulation set for a heat transfer catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable pump adapted to pump heat transfer fluid through the catheter from the fluid reservoir, a single-use, disposable filter assembly adapted to remove impurities from the heat transfer fluid, a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the fluid reservoir, pump, filter assembly, heat exchanger, and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating the temperature and pressure sensor block member and fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.

RELATED APPLICATIONS

[0001] This application is a Provisional-to-Utility Conversion of andclaims prioity to U.S. application Ser. No. 60/247,203, entitled“Improved Circulation Set for Temperature-Controlled Catheter and Methodof Using Same,” filed on Nov. 7, 2000.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates, in general, to a circulation setfor a temperature-controlled catheter and, in particular, to acirculation set for a hypothermia catheter.

[0004] 2. Background Information

[0005] Numerous catheters exist for non-invasive treatment of a varietyof internal areas and regions of a patient. Many of these catheterscirculate a fluid through a distal portion of the catheter. An exampleof a type of catheter that may circulate fluid through a distal portionof the catheter is a hypothermia catheter. A hypothermia catheter isinserted into the bloodstream of a patient in order to induce partial ortotal body hypothermia. A hypothermia catheter may be used to reduce theeffects of certain bodily injuries to the brain as well as other organs.A hypothermia catheter may include a heat transfer element located at adistal portion of the catheter. A heat transfer fluid may be circulatedalong an internal portion of the heat transfer element, drawing heatfrom the heat transfer element. This, in turn, causes heat to be removedfrom blood flowing along an external surface of the heat transferelement, causing the resulting blood to be cooled. The collectivecomponents that supply fluid to the catheter and regulate thetemperature of the fluid being delivered to and/or returning from thedistal portion are referred to herein as the circulation set and mayinclude one or more of the following: a fluid reservoir, a pump, afilter, a heat exchanger, a temperature sensor, a pressure sensor, andtubing.

[0006] The inventors of the present invention have recognized that ashealth insurance companies constantly cut back on the amount they arewilling to pay for medical devices used in medical procedures, itimportant to produce a quality circulation set made of inexpensivecomponents. Drawbacks of circulation sets in the past are that many orall of the components of the set are made of relatively expensivenon-disposable components intended to be used numerous times beforebeing disposed of, any disposable components of the circulation set arenot coveniently separable from the non-disposable components, and thedisposable components that are used are not made of readily-availablecheap components. The inventors of the present invention have alsorecognized that it would be better for insurance reimbursement purposesif the circulation set was made of relatively inexpensive components andwas essentially disposable.

SUMMARY OF THE INVENTION

[0007] A first aspect of the invention involves a single-use, disposablecirculation set for a heat transfer catheter. The circulation setincludes a single-use, disposable fluid reservoir adapted to supply aheat transfer fluid to the catheter, a single-use, disposable pumpadapted to pump heat transfer fluid through the catheter from the fluidreservoir, a single-use, disposable filter assembly adapted to removeimpurities from the heat transfer fluid, a single-use, disposable heatexchanger member adapted for use with a heat exchanger for transferringheat between the heat exchanger and the fluid, a single-use, disposabletemperature and pressure sensor block member for use with a multi-use,non-disposable temperature and pressure sensor electronics member, asingle-use, disposable supply line communicating the fluid reservoir,pump, filter assembly, heat exchanger, and temperature and pressuresensor block member, and adapted to be connected to the catheter forsupplying heat transfer fluid to the catheter, and a single-use,disposable return line communicating the temperature and pressure sensorblock member and fluid reservoir, and adapted to be connected to thecatheter for returning heat transfer fluid to the fluid reservoir.

[0008] A second aspect of the invention involves a single-use,disposable circulation set for a catheter. The circulation set includesa single-use, disposable fluid reservoir adapted to supply a heattransfer fluid to the catheter, a single-use, disposable heat exchangermember adapted for use with a heat exchanger for transferring heatbetween the heat exchanger and the fluid, a single-use, disposabletemperature and pressure sensor block member for use with a multi-use,non-disposable temperature and pressure sensor electronics member, asingle-use, disposable supply line communicating the fluid reservoir,heat exchanger, and temperature and pressure sensor block member, andadapted to be connected to the catheter for supplying heat transferfluid to the catheter, and a single-use, disposable return linecommunicating the temperature and pressure sensor block member and fluidreservoir, and adapted to be connected to the catheter for returningheat transfer fluid to the fluid reservoir.

[0009] A third aspect of the invention involves a single-use, disposablecirculation set for a catheter. The circulation set includes asingle-use, disposable fluid reservoir adapted to supply a heat transferfluid to the catheter, a single-use, disposable temperature and pressuresensor block member for use with a multi-use, non-disposable temperatureand pressure sensor electronics member, a single-use, disposable supplyline communicating the fluid reservoir and temperature and pressuresensor block member, and adapted to be connected to the catheter forsupplying heat transfer fluid to the catheter, and a single-use,disposable return line communicating the temperature and pressure sensorblock member and fluid reservoir, and adapted to be connected to thecatheter for returning heat transfer fluid to the fluid reservoir.

[0010] A fourth aspect of the invention involves a single-use,disposable circulation set for a catheter. The circulation set includesa single-use, disposable fluid reservoir adapted to supply a heattransfer fluid to the catheter, a single-use, disposable heat exchangermember adapted for use with a heat exchanger for transferring heatbetween the heat exchanger and the fluid, a single-use, disposablesupply line communicating the fluid reservoir and heat exchanger, andadapted to be connected to the catheter for supplying heat transferfluid to the catheter, and a single-use, disposable return linecommunicating with the fluid reservoir, and adapted to be connected tothe catheter for returning heat transfer fluid to the fluid reservoir.

[0011] A fifth aspect of the invention involves a single-use, disposablecirculation set for a catheter. The circulation set includes asingle-use, disposable heat exchanger member adapted for use with a heatexchanger for transferring heat between the heat exchanger and thefluid, a single-use, disposable temperature and pressure sensor blockmember for use with a multi-use, non-disposable temperature and pressuresensor electronics member, a single-use, disposable supply linecommunicating the heat exchanger and temperature and pressure sensorblock member, and adapted to be connected to the catheter for supplyingheat transfer fluid to the catheter, and a single-use, disposable returnline communicating with the temperature and pressure sensor blockmember, and adapted to be connected to the catheter for returning heattransfer fluid from the catheter.

[0012] A sixth aspect of the invention involves a method of using acirculation set for a heat transfer catheter. The method includesattaching a single-use, disposable circulation set including a fluidreservoir, a pump, a heat exchanger member, a condition sensor member,supply line, and return line to the catheter, circulating heat transferfluid and controlling the temperature of the same through the catheterwith the circulation set, and disposing the circulation set after asingle use.

[0013] A seventh aspect of the invention involves a method of using acirculation set for a heat transfer catheter. The method includesproviding a single-use, disposable circulation set for the catheter, thecirculation set comprising a single-use, disposable fluid reservoiradapted to supply a heat transfer fluid to the catheter, a single-use,disposable pump adapted to pump heat transfer fluid through the catheterfrom the fluid reservoir, a single-use, disposable filter assemblyadapted to remove impurities from the heat transfer fluid, a single-use,disposable heat exchanger member adapted for use with a multi-use,non-disposable heat exchanger for transferring heat between the heatexchanger and the fluid, a single-use, disposable temperature andpressure sensor block member for use with a multi-use, non-disposabletemperature and pressure sensor electronics member, a single-use,disposable supply line communicating the fluid reservoir, pump, filterassembly, heat exchanger, and temperature and pressure sensor blockmember, and adapted to be connected to the catheter for supplying heattransfer fluid to the catheter, and a single-use, disposable return linecommunicating the temperature and pressure sensor block member and fluidreservoir, and adapted to be connected to the catheter for returningheat transfer fluid to the fluid reservoir; connecting the return lineand supply line to the catheter; coupling the single-use, disposabletemperature and pressure sensor block member with the multi-use,non-disposable temperature and pressure sensor electronics member;coupling the single-use, disposable heat exchanger member with themulti-use, non-disposable heat exchanger; circulating heat transferfluid and controlling the flow rate and temperature of the same throughthe catheter with the pump, heat exchanger, and the temperature andpressure sensor block member and electronics member; and disposing thecirculation set after a single use.

[0014] An eighth aspect of the invention involves a disposable fluidreservoir for supplying a heat transfer fluid to a circulation set of aheat transfer catheter, the circulation set including a supply line forsupplying heat transfer fluid to the heat transfer catheter for fluidcirculation purposes and a return line for returning heat transfer fluidto the fluid reservoir for fluid circulation purposes. The fluidreservoir includes an intravenous (“IV”) bag normally used for theintravenous delivery of one or more fluids to the vasculature of apatient, the bag including a top and a bottom, an inlet line locatedwithin the bag and adapted to communicate with the return line forreturning fluid to the bag during circulation, and an outlet linelocated within the bag and adapted to communicate with the supply linefor supplying fluid to the catheter during circulation.

[0015] A ninth aspect of the invention involves a fluid reservoir forsupplying a heat transfer fluid to a circulation set of a heat transfercatheter, the circulation set including a supply line for supplying heattransfer fluid to the heat transfer catheter for fluid circulationpurposes and a return line for returning heat transfer fluid to thefluid reservoir for fluid circulation purposes. The fluid reservoirincludes a fluid reservoir body including a top and a bottom, anair-removal mechanism located in the body near the top of the body, aninlet line including an outlet located within the body, the inlet lineadapted to communicate with the return line for returning fluid to thebody during circulation, an outlet line including an inlet located atleast partially within the body, the outlet line adapted to communicatewith the supply line for supplying fluid to the catheter duringcirculation, and wherein the outlet of the inlet line is located closerto the air-removal mechanism than the inlet of the outlet line.

[0016] A tenth aspect of the invention involves a method of using afluid reservoir in a circulation set for a heat transfer catheter, thecirculation set including a supply line for supplying heat transferfluid to the catheter for fluid circulation purposes and a return linefor returning heat transfer fluid to the fluid reservoir for fluidcirculation purposes. The method includes using intravenous (“IV”) bagnormally used for the intravenous delivery of one or more fluids to thevasculature of a patient as a fluid reservoir in a circulation set for aheat transfer catheter, an inlet line located within the IV bag andadapted to communicate with the return line for returning fluid to theIV bag during circulation, and an outlet line located within the IV bagand adapted to communicate with the supply line for supplying fluid tothe catheter during circulation; circulating heat transfer fluid fromthe catheter through the return line, into the inlet line, through theIV bag, out the outlet line, and through the supply line to thecatheter; and disposing the IV bag after a single use.

[0017] An eleventh aspect of the invention involves a method of using afluid reservoir in a circulation set for a heat transfer catheter, thecirculation set including a supply line for supplying heat transferfluid to the catheter for fluid circulation purposes and a return linefor returning heat transfer fluid to the fluid reservoir for fluidcirculation purposes. The method includes providing a fluid reservoir,the fluid reservoir including a fluid reservoir body, an air-removalmechanism located in the body, an inlet line including an outlet locatedwithin the body, the inlet line adapted to communicate with the returnline for returning fluid to the body during circulation, an outlet lineincluding an inlet located at least partially within the body, theoutlet line adapted to communicate with the supply line for supplyingfluid to the catheter during circulation, and wherein the outlet of theinlet line is located closer to the air-removal mechanism than the inletof the outlet line; circulating heat transfer fluid from the catheterthrough the return line, into the inlet line, through the fluidreservoir body, out the outlet line, and through the supply line to thecatheter; and removing air from the circulation set with the air-removalmechanism.

[0018] A twelfth aspect of the invention involves a temperature andpressure sensor assembly of a circulation set of a heat transfercatheter for measuring temperature and pressure of a heat transfer fluidflowing through a supply line for supplying heat transfer fluid to acatheter for fluid circulation purposes and a return line for returningheat transfer fluid from the catheter for fluid circulation purposes.The temperature and pressure sensor assembly includes a multi-use,non-disposable temperature and pressure sensor electronics member, and asingle-use, disposable temperature and pressure sensor block memberremovably coupled to the electronics member so that the block member maybe discarded after a single use and the electronics member may be usedmultiple times with different disposable block assemblies, the blockmember adapted to communicate with the supply line and return line.

[0019] A thirteenth aspect of the invention involves a single-use,disposable temperature and pressure sensor block member of a temperatureand pressure sensor assembly of a circulation set of a heat transfercatheter for measuring temperature and pressure of a heat transfer fluidflowing through a supply line for supplying heat transfer fluid to acatheter for fluid circulation purposes and a return line for returningheat transfer fluid from the catheter for fluid circulation purposes.The temperature and pressure sensor block member includes a single-use,disposable temperature and pressure sensor block member adapted to beremovably coupled to a multi-use, non-disposable temperature andpressure sensor electronics member so that the block member may bediscarded after a single use and the electronics member may be usedmultiple times with different disposable block assemblies. The blockmember includes a pressure sensor hole adapted to communicate with asupply lumen and receive a pressure sensor of the electronics member, atemperature sensor hole adapted to communicate with the supply lumen andreceive a temperature sensor of the electronics member, a pressuresensor hole adapted to communicate with a return lumen and receive apressure sensor of the electronics member, and a temperature sensor holeadapted to communicate with the return lumen and receive a temperaturesensor of the electronics member.

[0020] A fourteenth aspect of the invention involves a method of using asingle-use, disposable temperature and pressure sensor block member of atemperature and pressure sensor assembly of a circulation set for a heattransfer catheter. The method includes removably attaching a single-use,disposable temperature and pressure sensor block member of a temperatureand pressure sensor assembly to a multi-use, non-disposable temperatureand pressure sensor electronics member; coupling the single-use,disposable temperature and pressure sensor block member to the heattransfer catheter; circulating heat transfer fluid through the blockmember and heat transfer catheter; sensing temperature and pressure ofheat transfer fluid flowing through the block member; and disposing theblock member but not the electronics member after a single use of theheat transfer catheter.

[0021] A fifteenth aspect of the invention involves a method of using asingle-use, disposable temperature and pressure sensor block member of atemperature and pressure sensor assembly of a circulation set for a heattransfer catheter. The method includes removably attaching a single-use,disposable temperature and pressure sensor block member of a temperatureand pressure sensor assembly to a multi-use, non-disposable temperatureand pressure sensor electronics member. The block member includes asupply lumen adapted to be coupled to the heat transfer catheter fordelivery of heat transfer fluid thereto, a return lumen adapted to becoupled to the heat transfer catheter for delivery of heat transferfluid therefrom, a pressure sensor hole adapted to communicate with thesupply lumen and receive a sensor of the electronics member, atemperature sensor hole adapted to communicate with the supply lumen andreceive a temperature sensor of the electronics member, a pressuresensor hole adapted to communicate with the return lumen and receive apressure sensor of the electronics member, and a temperature sensor holeadapted to communicate with the return lumen and receive a temperaturesensor of the electronics member; coupling the supply lumen and returnlumen of the block member with the heat transfer catheter; circulatingheat transfer fluid through the supply lumen of the block member, heattransfer catheter, and return lumen of the block member; sensingtemperature and pressure of heat transfer fluid flowing through thesupply lumen of the block member with the temperature and pressuresensors of the electronics member and sensing temperature and pressureof heat transfer fluid flowing through the return lumen of the blockmember with the temperature and pressure sensors of the electronicsmember; and disposing the block member but not the electronics memberafter a single use of the heat transfer catheter.

[0022] A sixteenth aspect of the invention involves a method of using aheat exchanger member in a circulation set for a heat transfer catheter,the circulation set including a heat exchanger adapted to transfer heatbetween the heat exchanger and heat transfer fluid within the heatexchanger member for temperature control of the heat transfer fluid. Themethod includes providing a single-use, disposable heat exchanger memberwith the heat exchanger, the heat exchanger member including at leastone passage adapted to allow heat transfer fluid to flow therethrough;transferring heat between the heat exchanger and the heat transfer fluidin the heat exchanger member, either to the heat transfer fluid from theheat exchanger or from the heat transfer fluid to the heat exchanger;and disposing the heat exchanger member, but not the heat exchangerafter a single use of the heat transfer catheter.

[0023] A seventeenth aspect of the invention involves a method of usinga heat exchanger member in a circulation set for a heat transfercatheter, the circulation set including a heat exchanger adapted totransfer heat between the heat exchanger and heat transfer fluid withinthe heat exchanger member for temperature control of the heat transferfluid. The method includes providing a single-use, disposable IV orintravenous bag normally used for the intravenous delivery of one ormore fluids to the vasculature of a patient as a heat exchanger memberwith the heat exchanger, the IV bag including at least one passageadapted to allow heat transfer fluid to flow therethrough; transferringheat between the heat exchanger and the heat transfer fluid in the IVbag, either to the heat transfer fluid from the heat exchanger or fromthe heat transfer fluid to the heat exchanger; and disposing the IV bagbut not the heat exchanger after a single use of the heat transfercatheter.

[0024] An eighteenth aspect of the invention involves a heat exchangerof a circulation set for a heat transfer catheter. The heat exchangerincludes a pair of heat exchanger mold members each including aninsulative body with an inner surface, a heat conductive face bonded tothe inner surface of the face, and one or more heat transfer liquidpaths located between the inner surface of the insulative body and theheat conductive face. The heat conductive face includes a moldconfiguration and is adapted, when placed together with the oppositeface, to receive a disposable heat exchanger member and shape thedisposable heat exchanger member into one or more heat transfer pathsfor transferring a heat transfer fluid therethrough.

[0025] A nineteenth aspect of the invention involves a method ofidentifying a heat transfer catheter or heat transfer element of a heattransfer catheter. The method includes measuring catheter pressure at avariety of heat transfer fluid flow rates; determining a slope of a bestfit line through a variety of data points determined by the measuringstep; and identifying the heat transfer catheter or heat transferelement by comparing the slope determined by the determining step toestablished slopes for a variety of different heat transfer catheters orheat transfer elements. In an implementation of the invention, themethod further includes controlling one or more operational parametersof the catheter or heat transfer element based on the heat transfercatheter or heat transfer element identified.

[0026] The novel features of this invention, as well as the inventionitself, will be best understood from the attached drawings, taken alongwith the following description, in which similar reference charactersrefer to similar parts, and in which:

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The drawings illustrate the design and utility of preferredembodiments of the present invention, in which:

[0028]FIG. 1 is a perspective view of a heat transfer catheter systemincluding a circulation set constructed in accordance with an embodimentof the invention;

[0029]FIG. 2 is a cross-sectional view of an embodiment of a distalportion of a heat transfer catheter along with a side-elevational viewof an embodiment of a proximal portion of the catheter that may be usedwith the circulation set illustrated in FIG. 1;

[0030]FIG. 3 is a schematic diagram of the circulation set illustratedin FIG. 1;

[0031]FIG. 4 is an exploded perspective view of an embodiment of adisposable heat exchanger that may be used in the circulation set of thepresent invention.

[0032]FIG. 5 is a cross sectional view of the heat exchanger illustratedin FIG. 4.

[0033]FIGS. 6A and 6B are perspective views of the manifold portions ofthe heat exchanger illustrated in FIG. 4.

[0034]FIG. 7 is a perspective view of a temperature and pressure sensorassembly constructed in accordance with an embodiment of the invention;

[0035]FIG. 8 is an exploded perspective view of the temperature andpressure sensor assembly illustrated in FIG. 7.

[0036]FIG. 9 is an exploded side-elevational view of the temperature andpressure sensor assembly illustrated in FIG. 7.

[0037]FIG. 10 is an exploded perspective view of the temperature andpressure sensor assembly illustrated in FIG. 7, but from a differentvantage point from that of FIG. 8.

[0038]FIG. 11 is an exemplary graph of a pump motor speed versus timefor a pump of the circulation set illustrated in FIG. 1.

[0039]FIG. 12 is an exemplary graph of pressure versus pump motor speedfor a 10 F. heat transfer catheter and a 14 F. heat transfer catheterused with the circulation set illustrated in FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

[0040] With reference to FIG. 1, an embodiment of a heat transfercatheter system 20 includes a heat transfer catheter 24, a controlsystem 26, and a circulation set 28 housed by the control unit system26. The control system 26 may be equipped with an output display 36 andinput keys 40 to facilitate user interaction with the control system 26.A hood 42 is pivotally connected to a control unit housing 44 forcovering much of the circulation set 28.

[0041] With reference additionally to FIG. 2, in a preferred embodiment,the catheter 24 is a heat transfer catheter such as, but not by way oflimitation, a hypothermia catheter capable of intravascular regulationof the temperature of a patient's body or one or more selected organs.The catheter 24 may include a heat transfer element 48 located at adistal portion thereof. In the embodiment of the heat transfer elementshown, the heat transfer element 48 includes a supply lumen 50 and areturn lumen 52. The supply lumen 50 and return lumen 52 preferablyterminate at respective distal points in a distal portion of the heattransfer element 48 and terminate at respective proximal points at asupply lumen port 54 and a return lumen port 56 in catheter handle 58.

[0042] The heat transfer element 48 may be placed in the vasculature ofthe patient to absorb heat from or deliver heat to surrounding bloodflowing along the heat transfer element 48, thereby regulating thetemperature of a patient's body or one or more selected organs. In ananalogous fashion, the heat transfer element 48 may be used within avolume of tissue to regulate the tissue temperature by absorbing heatfrom or delivering heat to a selected volume of tissue. In the lattercase, heat transfer is predominantly by conduction.

[0043] In an exemplary application, the heat transfer catheter 24 may beused to cool the brain. One or more other organs, as well as the wholebody, may also be cooled and/or heated, i.e., temperature controlled.The common carotid artery supplies blood to the head and brain. Theinternal carotid artery branches off the common carotid artery to supplyblood to the anterior cerebrum. The heat transfer element 48 may beplaced into the common carotid artery or into both the common carotidartery and the internal carotid artery via the femoral artery or otherwell known vascular routes. Heat transfer fluid supplied, chilled, andcirculated by the circulation set 28 causes the heat transfer element 48to draw heat from the surrounding blood flow in the carotid artery orinternal carotid artery, causing cooling of the brain to, for example,reduce the effects of certain body injuries to the brain.

[0044] Although the catheter 24 has been described as including aspecific heat transfer element 48, it will be readily apparent to thoseskilled in the art that the circulation set of the present invention maybe used with heat transfer catheters including heat transfer elementsother than the specific heat transfer element 48 described above.Further, although the circulation set 28 is described in conjunctionwith a heat transfer catheter, it will be readily apparent to thoseskilled in the art that the circulation set of the present invention maybe used in conjunction with catheters other than hypothermia or heattransfer catheters. For example, the circulation set may be used withcatheters that require a fluid to be supplied to and/or circulatedthrough the catheter.

[0045] Circulation Set

[0046] With reference to FIGS. 1 and 3, an embodiment of the circulationset 28 will now be described. The circulation set 28 may include one ormore of the following: a fluid reservoir 60, a pump 64, a filter 68, aheat exchanger 72, a temperature and pressure sensor assembly 76, asupply line 80, and a return line 84. The supply lumen port 54 andreturn lumen portion are coupled with respective supply lines 80 andreturn lines 84 of the circulation set 28. The supply line 80 and returnline 84 are preferably comprised of one or more pieces of tubing,connectors, etc. for joining the aforementioned components of thecirculation set 28 to the supply lumen port 54 and return lumen port 56.The circulation set 28 may supply, filter, circulate, and/or be used tomonitor the temperature and pressure of the heat transfer fluid for thecatheter 24. Each of these components will now be described in turn.

[0047] Fluid Reservoir

[0048] In a preferred embodiment, the fluid reservoir 60 is a modified250 ml IV bag made of PVC. The fluid reservoir 60 may be filled with aworking fluid such as, but not by way of limitation, saline, freon, orperflourocarbon. In order to prevent the working fluid from causing EMIinterference with other electronic devices used in the operating room,the working fluid may be a non-ionic fluid such as, but not by way oflimitation, D5W, D5W with 1.5% glycerine, Sorbitol-Mannitol, andRinger's Solution.

[0049] The fluid reservoir 60 may be used to prime the lines 80, 84 andlumens 50, 52 of the system 20. The fluid reservoir 60 includes a supplyor inlet tube 90 that communicates at an inlet 91 with the return line84 and communicates at an opposite end or outlet 92 with an inside 94 ofthe reservoir 60. The fluid reservoir 60 also includes a return oroutlet tube 96 that communicates at one end with the supply line 80 andcommunicates at an opposite end or inlet 98, with the inside 94 of thereservoir 60.

[0050] The fluid reservoir 60 preferably also includes a mechanism 99for purging, venting or removing air from the system 20. The air purgingmechanism is used to remove air from the lines 80, 84 and lumens 50, 52of the system 20 and, in a preferred embodiment, includes a needlelesspolycarbonate valve 100 with a polycarbonate vented spike 101. Theremoval or purging of air from the system 20 is important for maximizingthe pressure in the system 20, maximizing heat transfer at the heattransfer element 48, and preventing air from possibly entering the bloodstream of the patient caused by a break or leak in the catheter 24. Theoutlet 92 of the supply tube 90 may be located closer to the air purgingmechanism 99 than the inlet 98 of the return tube 96 or adjacent to theair purging mechanism 99 to inhibit air bubbles supplied by the supplytube 90 from directly entering the return tube 96 without theopportunity to be removed by the air purging mechanism 99. The purgingcycle will be discussed in greater detail below.

[0051] In an alternative embodiment of the circulation set, the fluidreservoir 60 may supply or prime the system 20 without recirculation ofworking fluid therethrough. In this embodiment, the reservoir 60 may notinclude the supply tube 90 and the air removal mechanism 99. The airremoval mechanism 99 may be located in the circulation set 28 outside ofthe fluid reservoir 60.

[0052] The pump 64 is may be a disposable, plastic micro-pump that isdisposed of or discarded with the other disposable components of thecirculation set 28 after a single use. The pump 64 is used to draw theheat transfer fluid from the fluid reservoir and circulate the fluidthroughout the lines 80, 84 and lumens 50, 52. In an alternativeembodiment, the pump may be a permanent, non-disposable pump.

[0053] Filter

[0054] The filter 68 is preferably a 5 micron filter carried by male andfemale housing members. The filter 68 removes impurities from thecirculating heat transfer fluid. In other embodiments of the circulationset 28, the circulation set 28 may include more than one filter 68, thecirculation set 28 may include no filters 68, or the filter 68 may be apart of one or more components of the circulation set 28.

[0055] Heat Exchanger

[0056] In the embodiment of the circulation set illustrated in FIGS. 1and 3, the heat exchanger 72 is a stainless steel tubing 73 that sits ina bath 102 of a second heat transfer fluid made of a biocompatible fluidsuch as, but not limited to, galden or ethylene glycol. This is anexample of a wet heat exchanger because the tubing 73 resides within aliquid heat transfer fluid. A second heat exchanger (not shown) locatedin the control unit housing 44 regulates the temperature of the bath 102for controlling the temperature of the heat transfer fluid in the system20. The heat exchanger 72 is a reusable, non-disposable, wet heatexchanger.

[0057] With reference to FIGS. 4-6, an embodiment of a dry heatexchanger 120 including a disposable, single-use heat exchanger member122 may be used in the circulation set 28. The heat exchanger member 122is removably securable within heat exchanger mold members 124, 126.

[0058] The heat exchanger mold members 124, 126 are preferablyconstructed of a thermoplastic insulative material and may includematching, mirrored serpentine grooves 128 therein. The serpentinegrooves 128 terminate at one end in an inlet groove 130 and terminate atan opposite end in an outlet groove 132. The inlet groove 130 and outletgroove 132 accommodate inlet tube 142 and outlet tube 144 of thedisposable heat exchanger member 222 and corresponding connection tubes(not shown) for connecting to the supply line 80. In an alternativeembodiment, each heat exchanger mold member 124, 126 may have more thanone inlet and/or outlet. Instead of serpentine grooves 128, each heatexchanger mold member may include one or more cavities that formreservoirs that heat transfer fluid flows through. First and second heatexchanger surfaces 134, 136 are located on inner faces of the moldmembers 124, 126. In a preferred embodiment, the heat exchanger surfaces134, 136 are stamped stainless steel pieces of sheet metal that arebonded to the inner faces of the mold members 124, 126 so as to formheat transfer paths 138 (FIG. 5) therebetween. The heat exchangersurfaces 134, 136 preferably have serpentine grooves 140 stampedtherein. In an alternative embodiment of the invention, each groove 140may have a shape that is other than serpentine or there may be more orless channels in each serpentine groove 140. The heat exchanger surfaces134, 136 isolate the disposable heat exchanger member 122 from the heattransfer fluid flowing through the heat transfer paths 138, making theheat exchanger a “dry” heat exchanger in that the heat transfer fluid,e.g., ethylene glycol, does not contact the external surface of thedisposable heat exchanger member 126.

[0059] The disposable heat exchanger member 122 is preferablyconstructed of an IV bag and may include the aforementioned inlet tube142 and outlet tube 144 welded to a bag body 146.

[0060] In use, the heat exchanger 120 is opened by separating the firstheat exchanger mold member 124 and the second heat exchanger mold member126, the disposable heat exchanger member 122 is placed therebetween,and the heat exchanger 120 is closed by bringing the first heatexchanger mold member 124 and the second heat exchanger mold member 126together. When the heat exchanger 120 is closed, the disposable heatexchanger member 122 conforms to the shape of the serpentine grooves140, forming corresponding serpentine fluid passages 148 in thedisposable heat exchanger member 122. As working fluid flows through theserpentine passages 148, heat transferred between the heat transferfluid in the heat transfer paths 138 and heat exchanger surfaces 134,136 causes corresponding heat transfer between the heat exchangersurfaces 134, 136 and the working fluid in the serpentine passages 148.After use, the heat exchanger member 120 is opened by separating thefirst heat exchanger mold member 124 and the second heat exchanger moldmember 126, and the disposable heat exchanger member 120 is disposed ofwith the rest of the disposable components of the circulation set 28.

[0061] Thus, the heat exchanger 120 is a dry heat exchanger because theexternal surface of the disposable heat exchanger member 120 does notcontact a liquid, making it not as messy as the aforementioned coiledheat exchanger 72 that resides in a liquid bath. The heat exchangermember 122 is inexpensive and conveniently disposable after a singleuse.

[0062] In alternative embodiments of the invention, the heat exchangermay have a different construction. For example, a pair of heatexchangers 120 may be stacked on each other in a “double-decker”fashion, sharing a common heat exchanger mold member, the disposableheat exchanger member 120 may include a bag with serpentine orother-shaped passages already formed therein, or the disposable heatexchanger member 120 may be comprised of a stainless steal tube shapedin serpentine or other pattern.

[0063] Temperature and Pressure Sensor Assembly

[0064] With reference to FIGS. 7-10, the temperature and pressure sensorassembly 76 will now be described in more detail. The temperature andpressure sensor assembly 76 is used for measuring the temperature andthe pressure of the heat transfer fluid in the supply line 80 before itenters the catheter 24, and measuring the temperature and the pressureof the heat transfer fluid in the return line 84, after it leaves thecatheter 24. These measurements are important for determining thepressure of the heat transfer fluid flowing through the catheter 24 andthe heat transfer that occurs at the heat transfer element 48 of thecatheter 24. Heating or cooling efficiency of the heat transfer element48 is optimized by maximizing the pressure or flow rate of working fluidthrough the catheter. Although the assembly 76 is described as atemperature and pressure assembly, the assembly 76 may be used tomeasure only temperature or pressure. Further, the assembly 76 may beused for measuring other physical characteristics of the working fluid.

[0065] The temperature and pressure sensor assembly 76 includes two maincomponents, a multi-use, fixed, non-disposable temperature and pressuresensor electronics member 210 and a single-use, disposable temperatureand pressure sensor block member 212.

[0066] With reference to FIGS. 7-8, the temperature and pressure sensorelectronics member 210 includes a base 214 and a latch 216 pivotallycoupled thereto by a pin 218. The base 214 includes an upper surface 220and a skirt 222 that together define a receiving area 224 for thetemperature and pressure block member 212. The base 214 includes firstand second round pressure transducer holes 226, 227 that receivecorresponding first and second pressure transducers 228, 229 and firstand second round thermocouple holes 230, 231 that receive correspondingfirst and second thermocouples 232, 233. The pressure transducers 228,229 and thermocouples 232, 233 are coupled to electronic circuitry on anundersurface of the base 214. The electronic circuitry is coupled to thecontrol system 26 via appropriate wiring. The base 214 includes a slopedsurface 236 that terminates in a shoulder portion 238. The latch 216includes a corresponding catch portion 240 that is biased outward andengages the shoulder portion 238 when the latch 216 is pivoted onto thebase 214. The latch 216 also includes a protruding release member 242that may be manipulated by a user's fingers to disengage the catchportion 240 of the latch 216 from the shoulder portion 238 of the base214.

[0067] With reference to FIGS. 9 and 10, the disposable temperature andpressure sensor block member 212 includes a polycarbonate block or base250 having first and second longitudinally extending lumens or tubes252, 254 extending therethrough. The longitudinally extending lumens252, 254 communicate with corresponding first and second pressuretransducer wells 256, 258 (FIG. 9) and first and second thermocouplewells 260, 262. The pressure transducer wells 256, 258 include centralholes 264 that communicate the respective longitudinally extendinglumens 252, 254, an inner annular raised portion 266, an outer annularrecessed portion 268, and an annular wall 270. The thermocouple wells260, 262 include central holes 272 that communicate with the respectivelongitudinally extending lumens 252, 254, an inner annular recessedportion 274, an outer annular raised portion 276, and an annular wall278.

[0068] Each pressure transducer well 256, 258 includes an O-Ring seal280 fixed on the outer annular recessed portion 268, a pressure sensordiaphragm 282 fixed on the O-Ring seal 280, over the inner annularraised portion 266, and a pressure sensor bushing 284 fixed to theannular wall 270, over the diaphragm 282. Each thermocouple well 260,262 includes an O-Ring seal 290 fixed on the inner annular recessedportion 274, a sensor connection tube 292 fixed on the O-Ring seal 290and extending into the central hole 272, and a temperature sensorbushing 294 fixed to the annular wall 278, over the sensor connectiontube 292.

[0069] The temperature and pressure sensor assembly 76 is assembled byfitting the temperature and pressure block member 212 onto thetemperature and pressure electronics member 210 so that the pressuretransducers 228, 229 and thermocouples 232, 233 of the electronicsmember 210 mate with the corresponding pressure transducer wells 256,258 and thermocouple wells 260, 262 of the block member 212. The latch216 is then pivoted to the locked or engaged position so that the catchportion 240 of the latch 216 engages the shoulder portion 238 of thebase 214. This locks the block member 212 to the electronics member 210.

[0070] After a single use of the circulation set 28 or operation usingthe circulation set 28, the block member 212 is preferably removed fromthe electronics member 210 and disposed of. This is accomplished bydisengaging the catch portion 240 of the latch 216 from the shoulderportion 238 of the base 214 by pulling on the release member 242. Theblock member 212 along with the other disposable components of thecirculation set 28 are then disposed of. Thus, the only reusablecomponent of the pressure and temperature assembly 76 is the temperatureand pressure electronics member 210. The above-described constructionand configuration of the block member 212 allows for its inexpensivemanufacture, and thus, disposability, and the reusability of theelectronics member 210 without contaminating any elements of theelectronics member 210.

[0071] As discussed infra, the air purging mechanism 99 is used toremove air from the lines 80, 84 and lumens 50, 52 of the system 20.Removing air from the system 20 maximizes the pressure in the system 20,maximizes heat transfer at the heat transfer element 48, and reduces therisk of air entering the blood stream of the patient. The air purgingmechanism 99 is employed during a purge phase before each use of thesystem 20. The purge phase is important for identification of the typeof catheter being used and for early detection of problems with thesystem 20.

[0072] With reference to FIGS. 11 and 12, a method of automaticallyidentifying a catheter connected to the circulation set 28 orautomatically identifying a heat transfer element attached to a catheterthat is connected to a circulation set 28 based on a pressure reading inthe circulation set 28 will now be described.

[0073]FIG. 11 is a graph generally illustrating pump motor speed versustime for exemplary purge, idle, and run cycles of the catheter system20. The pump motor speed is representative of the fluid flow ratethrough the system 20. In the purge routine, the fluid flow rate isgradually increased in discrete steps.

[0074] With reference additionally to FIG. 12, each catheter 24 (e.g.,10 F, 14 F, etc.) or heat transfer element 48 connected to a catheter 24has its own unique flow resistance, i.e., pressure versus flow response.If during each discrete step of the purge cycle, both the inlet pressureof the catheter 24 and the pump speed are measured, a straight line maybe drawn through the measured data points and a slope computed. FIG. 12illustrates such sloped lines for a 10 F catheter and a 14 F catheterattached to the circulation set 28. The catheter 24 or heat transferelement of a catheter 24 used with the circulation set 28 may beautomatically identified by comparing the computed slope with a list ofsimilarly computed slopes obtained empirically from a set of availablecatheters. After automatically identifying the catheter being used, thecontrol system 26 may apply the corresponding optimal parameters foroperation of the catheter 24. The computed slope may also be used todetermine if a problem has occurred in the system 20, e.g., fluidleakage, if the computed slope does not match that of a specificreference catheter.

[0075] An exemplary practice of the present invention, for arterialapplications, is illustrated in the following non-limiting example.

Exemplary Procedure

[0076] 1. The patient is initially assessed, resuscitated, andstabilized.

[0077] 2. The procedure is carried out in an angiography suite orsurgical suite equipped with fluoroscopy.

[0078] 3. Because the catheter is placed into the common carotid artery,it is important to determine the presence of stenotic atheromatouslesions. A carotid duplex (Doppler/ultrasound) scan can quickly andnon-invasively make this determination. The ideal location for placementof the catheter is in the left carotid so this may be scanned first. Ifdisease is present, then the right carotid artery can be assessed. Thistest can be used to detect the presence of proximal common carotidlesions by observing the slope of the systolic upstroke and the shape ofthe pulsation. Although these lesions are rare, they could inhibit theplacement of the catheter. Examination of the peak blood flow velocitiesin the internal carotid can determine the presence of internal carotidartery lesions. Although the catheter is placed proximally to suchlesions, the catheter may exacerbate the compromised blood flow createdby these lesions. Peak systolic velocities greater that 130 cm/sec andpeak diastolic velocities >100 cm/sec in the internal indicate thepresence of at least 70% stenosis. Stenosis of 70% or more may warrantthe placement of a stent to open up the internal artery diameter.

[0079] 4. The ultrasound can also be used to determine the vesseldiameter and the blood flow and the catheter with the appropriatelysized heat transfer element are selected.

[0080] 5. After assessment of the arteries, the patient's inguinalregion is sterilely prepped and infiltrated with lidocaine.

[0081] 6. The femoral artery is cannulated and a guide wire may beinserted to the desired carotid artery. Placement of the guide wire isconfirmed with fluoroscopy.

[0082] 7. An angiographic catheter can be fed over the wire and contrastmedia injected into the artery to further to assess the anatomy of thecarotid.

[0083] 8. Alternatively, the femoral artery is cannulated and a 10-12.5french (f) introducer sheath is placed.

[0084] 9. A guide catheter is placed into the desired common carotidartery. If a guiding catheter is placed, it can be used to delivercontrast media directly to further assess carotid anatomy.

[0085] 10. A 10 f-12 f (3.3-4.0 mm) (approximate) cooling catheter issubsequently filled with saline and all air bubbles are removed.

[0086] 11. The cooling catheter is placed into the carotid artery viathe guiding catheter or over the guidewire. Placement is confirmed withfluoroscopy.

[0087] 12. The cooling catheter is connected to the aforementionedcirculation set. An ionic or non-ionic heat transfer fluid is suppliedby the fluid reservoir or IV bag.

[0088] 13. Cooling is initiated by starting the pump and the heattransfer fluid is circulated through the circulation set and catheter at3-8 cc/sec. The heat transfer fluid travels through the circulation setand is cooled to approximately 1° C. The fluid travels through the heatexchanger and is simultaneously cooled. The air purge mechanism is usedto remove air bubbles or pockets from the fluid lines. Priming andpurging may also be done before the cooling catheter is introduced intothe patient's body. As discussed above, the control system mayautomatically identify the type of catheter or heat transfer element onthe catheter based on catheter inlet pressure readings made during thepurge cycle. Once the identity of the catheter or heat transfer elementon the catheter is known, the control system may then determine optimumoperating parameters for the catheter/heat transfer element or if aproblem exists.

[0089] 14. The heat transfer fluid subsequently enters the coolingcatheter where it is delivered to the heat transfer element. The heattransfer fluid is warmed to approximately 5-7° C. as it travels alongthe inner lumen of the catheter shaft to the end of the heat transferelement.

[0090] 15. The heat transfer fluid then flows back through the heattransfer element in contact with the inner metallic surface. The heattransfer fluid is further warmed in the heat transfer element to 12-15°C., and in the process, heat is absorbed from the blood, cooling theblood to 30° C. to 32° C.

[0091] 16. The chilled blood then goes on to chill the brain. It isestimated that 15-30 minutes will be required to cool the brain to 30 to32° C.

[0092] 17. The warmed heat transfer fluid travels back down the outerlumen of the catheter shaft and back through the circulation set whereit is cooled to 1° C.

[0093] 18. The pressure drops along the length of the circuit areestimated to be, e.g., 6 atmospheres.

[0094] 19. The cooling can be adjusted by increasing or decreasing theflow rate of the heat transfer fluid, or by changing the temperature ofthe heat transfer fluid. The temperature and pressure of the heattransfer fluid entering the catheter and exiting the catheter ismonitored with the temperature and pressure sensor assembly. Monitoringtemperature and pressure at these points yield the temperature andpressure drop through the catheter. Monitoring the temperature andpressure drop of the heat transfer fluid through the catheter will allowthe flow rate and cooling to be adjusted to maintain the desired coolingeffect.

[0095] 20. The catheter is left in place to provide cooling for up to ormore than 12 to 24 hours.

[0096] 21. If desired, warm heat transfer fluid can be circulated topromote warming of the brain at the end of the procedure.

[0097] 22. After the procedure is completed, the supply line and returnline are disconnected from the catheter, and the temperature and sensorblock member is disconnected from the temperature and sensor electronicsmember. If the disposable heat exchanger member is used, the disposableheat exchanger member may be removed from the first and second heatexchanger mold members and disposed of along with the other disposablecomponents of the circulation set.

[0098] The invention has been described with respect to certainembodiments. It will be clear to one of skill in the art that variationsof the embodiments may be employed in the method of the invention.Accordingly, the invention is limited only by the scope of the appendedclaims.

What is claimed is:
 1. A single-use, disposable circulation set for aheat transfer catheter, comprising: a single-use, disposable fluidreservoir adapted to supply a heat transfer fluid to the catheter; asingle-use, disposable pump adapted to pump heat transfer fluid throughsaid catheter from said fluid reservoir; a single-use, disposable filterassembly adapted to remove impurities from said heat transfer fluid; asingle-use, disposable heat exchanger member adapted for use with a heatexchanger for transferring heat between said heat exchanger and saidfluid; a single-use, disposable temperature and pressure sensor blockmember for use with a multi-use, non-disposable temperature and pressuresensor electronics member; a single-use, disposable supply linecommunicating said fluid reservoir, pump, filter assembly, heatexchanger, and temperature and pressure sensor block member, and adaptedto be connected to said catheter for supplying heat transfer fluid tosaid catheter; and a single-use, disposable return line communicatingsaid temperature and pressure sensor block member and fluid reservoir,and adapted to be connected to said catheter for returning heat transferfluid to said fluid reservoir.
 2. The circulation set of claim 1,wherein said single-use, disposable temperature and pressure sensorblock member includes a block made of polycarbonate.
 3. The circulationset of claim 1, wherein said single-use, disposable temperature andpressure sensor block member includes a supply lumen in communicationwith said supply line and a return lumen in communication with saidreturn line.
 4. The circulation set of claim 3, wherein said single-use,disposable temperature and pressure sensor block member includes apressure sensor hole in communication with said supply lumen and adaptedto receive a pressure sensor of said electronics member, a temperaturesensor hole in communication with said supply lumen and adapted toreceive a temperature sensor of said electronics member, a pressuresensor hole in communication with said return lumen and adapted toreceive a pressure sensor of said electronics member, and a temperaturesensor hole in communication with said return lumen and adapted toreceive a temperature sensor of said electronics member.
 5. Thecirculation set of claim 4, further including a single-use, disposabletemperature sensor coupler adapted to be received by said temperaturesensor and communicate with said heat transfer fluid via saidtemperature sensor hole, said coupler made of a material having a highthermal conductivity so that said temperature sensor accurately sensesthe temperature of said heat transfer fluid without contacting said heattransfer fluid.
 6. The circulation set of claim 4, further including asingle-use, disposable pressure sensor membrane disposed in saidpressure sensor hole and adapted to be operatively associated with saidpressure sensor and communicate with said heat transfer fluid to sensethe pressure of said heat transfer fluid without contacting it.
 7. Thecirculation set of claim 1, wherein said fluid reservoir is an IV bag.8. The circulation set of claim 1, wherein said circulation set includesan air-removal mechanism.
 9. The circulation set of claim 8, whereinsaid fluid reservoir includes the air-removal mechanism.
 10. Thecirculation set of claim 9, wherein said return line terminates at anoutlet inside said fluid reservoir and said supply line terminates at aninlet inside said fluid reservoir.
 11. The circulation set of claim 10,wherein said outlet of said return line is located closer to saidair-removal mechanism than the inlet of said supply line.
 12. Thecirculation set of claim 11, wherein said outlet of said return line islocated adjacent to said air-removal mechanism.
 13. The circulation setof claim 1, wherein said heat exchanger member is adapted to be usedwith a dry heat exchanger so that an outer surface of said heatexchanger member does not contact a heat transfer liquid.
 14. Thecirculation set of claim 1, wherein said heat exchanger member is an IVbag adapted to be removably disposed between a pair of heat exchangermolds.
 15. The circulation set of claim 14, wherein said IV bag isadapted to be shaped into a serpentine heat transfer fluid path.
 16. Asingle-use, disposable circulation set for a catheter, comprising: asingle-use, disposable fluid reservoir adapted to supply a heat transferfluid to the catheter; a single-use, disposable heat exchanger memberadapted for use with a heat exchanger for transferring heat between saidheat exchanger and said fluid; a single-use, disposable temperature andpressure sensor block member for use with a multi-use, non-disposabletemperature and pressure sensor electronics member; a single-use,disposable supply line communicating said fluid reservoir, heatexchanger, and temperature and pressure sensor block member, and adaptedto be connected to said catheter for supplying heat transfer fluid tosaid catheter; and a single-use, disposable return line communicatingsaid temperature and pressure sensor block member and fluid reservoir,and adapted to be connected to said catheter for returning heat transferfluid to said fluid reservoir.
 17. A single-use, disposable circulationset for a catheter, comprising: a single-use, disposable fluid reservoiradapted to supply a heat transfer fluid to the catheter; a single-use,disposable temperature and pressure sensor block member for use with amulti-use, non-disposable temperature and pressure sensor electronicsmember; a single-use, disposable supply line communicating said fluidreservoir and temperature and pressure sensor block member, and adaptedto be connected to said catheter for supplying heat transfer fluid tosaid catheter; and a single-use, disposable return line communicatingsaid temperature and pressure sensor block member and fluid reservoir,and adapted to be connected to said catheter for returning heat transferfluid to said fluid reservoir.
 18. A single-use, disposable circulationset for a catheter, comprising: a single-use, disposable fluid reservoiradapted to supply a heat transfer fluid to the catheter; a single-use,disposable heat exchanger member adapted for use with a heat exchangerfor transferring heat between said heat exchanger and said fluid; asingle-use, disposable supply line communicating said fluid reservoirand heat exchanger, and adapted to be connected to said catheter forsupplying heat transfer fluid to said catheter; and a single-use,disposable return line communicating with said fluid reservoir, andadapted to be connected to said catheter for returning heat transferfluid to said fluid reservoir.
 19. A single-use, disposable circulationset for a catheter, comprising: a single-use, disposable heat exchangermember adapted for use with a heat exchanger for transferring heatbetween said heat exchanger and said fluid; a single-use, disposabletemperature and pressure sensor block member for use with a; multi-use,non-disposable temperature and pressure sensor electronics member; asingle-use, disposable supply line communicating said heat exchanger andtemperature and pressure sensor block member, and adapted to beconnected to said catheter for supplying heat transfer fluid to saidcatheter; and a single-use, disposable return line communicating withsaid temperature and pressure sensor block member, and adapted to beconnected to said catheter for returning heat transfer fluid from saidcatheter.
 20. A method of using a circulation set for a heat transfercatheter, comprising: attaching a single-use, disposable circulation setincluding a fluid reservoir, a pump, a heat exchanger member, acondition sensor member, supply line, and return line to the catheter;circulating heat transfer fluid and controlling the temperature of thesame through said catheter with said circulation set; disposing saidcirculation set after a single use.
 21. A method of using a circulationset for a heat transfer catheter, comprising: providing a single-use,disposable circulation set for the catheter, comprising: a single-use,disposable fluid reservoir adapted to supply a heat transfer fluid tothe catheter; a single-use, disposable pump adapted to pump heattransfer fluid through said catheter from said fluid reservoir; asingle-use, disposable filter assembly adapted to remove impurities fromsaid heat transfer fluid; a single-use, disposable heat exchanger memberadapted for use with a multi-use, non-disposable heat exchanger fortransferring heat between said heat exchanger and said fluid; asingle-use, disposable temperature and pressure sensor block member foruse with a multi-use, non-disposable temperature and pressure sensorelectronics member; a single-use, disposable supply line communicatingsaid fluid reservoir, pump, filter assembly, heat exchanger, andtemperature and pressure sensor block member, and adapted to beconnected to said catheter for supplying heat transfer fluid to saidcatheter; and a single-use, disposable return line communicating saidtemperature and pressure sensor block member and fluid reservoir, andadapted to be connected to said catheter for returning heat transferfluid to said fluid reservoir; connecting said return line and supplyline to said catheter; coupling said single-use, disposable temperatureand pressure sensor block member with said multi-use, non-disposabletemperature and pressure sensor electronics member; coupling saidsingle-use, disposable heat exchanger member with said multi-use,non-disposable heat exchanger; circulating heat transfer fluid andcontrolling the flow rate and temperature of the same through saidcatheter with said pump, heat exchanger, and said temperature andpressure sensor block member and electronics member; disposing saidcirculation set after a single use.
 22. The method of claim 21, whereinsaid single-use, disposable temperature and pressure sensor block memberincludes a block made of polycarbonate.
 23. The method of claim 21,wherein said single-use, disposable temperature and pressure sensorblock member includes a supply lumen in communication with said supplyline and a return lumen in communication with said return line.
 24. Themethod of claim 23, wherein said single-use, disposable temperature andpressure sensor block member includes a pressure sensor hole incommunication with said supply lumen and adapted to receive a pressuresensor of said electronics member, a temperature sensor hole incommunication with said supply lumen and adapted to receive atemperature sensor of said electronics member, a pressure sensor hole incommunication with said return lumen and adapted to receive a pressuresensor of said electronics member, and a temperature sensor hole incommunication with said return lumen and adapted to receive atemperature sensor of said electronics member.
 25. The method of claim24, further including a single-use, disposable temperature sensorcoupler adapted to be received by said temperature sensor andcommunicate with said heat transfer fluid via said temperature sensorhole, said coupler made of a material having a high thermal conductivityso that said temperature sensor accurately senses the temperature ofsaid heat transfer fluid without contacting said heat transfer fluid.26. The method of claim 24, further including a single-use, disposablepressure sensor membrane disposed in said pressure sensor hole andadapted to be operatively associated with said pressure sensor andcommunicate with said heat transfer fluid to sense the pressure of saidheat transfer fluid without contacting it.
 27. The method of claim 21,wherein said fluid reservoir is an IV bag.
 28. The method of claim 21,wherein said circulation set includes an air-removal mechanism.
 29. Themethod of claim 21, wherein said fluid reservoir includes an air-removalmechanism.
 30. The method of claim 29, wherein said return lineterminates at an outlet inside said fluid reservoir and said supply lineterminates at an inlet inside said fluid reservoir.
 31. The method ofclaim 30, wherein said outlet of said return line is located closer tosaid air-removal mechanism than the inlet of said supply line.
 32. Themethod of claim 31, wherein said outlet of said return line is locatedadjacent to said air-removal mechanism.
 33. The method of claim 21,wherein said heat exchanger member is adapted to be used with a dry heatexchanger so that an outer surface of said heat exchanger member doesnot contact a heat transfer liquid.
 34. The method of claim 21, whereinsaid heat exchanger member is an IV bag adapted to be removably disposedbetween a pair of heat exchanger molds.
 35. The method of claim 34,wherein said IV bag is adapted to be shaped into a serpentine heattransfer fluid path.
 36. A disposable fluid reservoir for supplying aheat transfer fluid to a circulation set of a heat transfer catheter,the circulation set including a supply line for supplying heat transferfluid to said heat transfer catheter for fluid circulation purposes anda return line for returning heat transfer fluid to said fluid reservoirfor fluid circulation purposes, the fluid reservoir comprising: anintravenous (“IV”) bag normally used for the intravenous delivery of oneor more fluids to the vasculature of a patient, said bag including a topand a bottom; an inlet line located within said bag and adapted tocommunicate with said return line for returning fluid to said bag duringcirculation; and an outlet line located within said bag and adapted tocommunicate with said supply line for supplying fluid to said catheterduring circulation.
 37. The fluid reservoir of claim 36, wherein said IVbag includes an air-removal mechanism.
 38. A fluid reservoir forsupplying a heat transfer fluid to a circulation set of a heat transfercatheter, the circulation set including a supply line for supplying heattransfer fluid to said heat transfer catheter for fluid circulationpurposes and a return line for returning heat transfer fluid to saidfluid reservoir for fluid circulation purposes, the fluid reservoircomprising: a fluid reservoir body including a top and a bottom; anair-removal mechanism located in the body near the top of said body; aninlet line including an outlet located within said body, said inlet lineadapted to communicate with said return line for returning fluid to saidbody during circulation; an outlet line including an inlet located atleast partially within said body, said outlet line adapted tocommunicate with said supply line for supplying fluid to said catheterduring circulation; and wherein the outlet of the inlet line is locatedcloser to said air-removal mechanism than the inlet of said outlet line.39. The reservoir of claim 38, wherein the outlet of said return line islocated adjacent to said air-removal mechanism.
 40. A method of using afluid reservoir in a circulation set for a heat transfer catheter, thecirculation set including a supply line for supplying heat transferfluid to said catheter for fluid circulation purposes and a return linefor returning heat transfer fluid to said fluid reservoir for fluidcirculation purposes, the method comprising: using intravenous (“IV”)bag normally used for the intravenous delivery of one or more fluids tothe vasculature of a patient as a fluid reservoir in a circulation setfor a heat transfer catheter, an inlet line located within said IV bagand adapted to communicate with said return line for returning fluid tosaid IV bag during circulation, and an outlet line located within saidIV bag and adapted to communicate with said supply line for supplyingfluid to said catheter during circulation; circulating heat transferfluid from said catheter through said return line, into said inlet line,through said IV bag, out said outlet line, and through said supply lineto said catheter; disposing said IV bag after a single use.
 41. Themethod of claim 40, wherein said IV bag includes an air-removalmechanism and the method further includes removing air from saidcirculation set with said air-removal mechanism.
 42. A method of using afluid reservoir in a circulation set for a heat transfer catheter, thecirculation set including a supply line for supplying heat transferfluid to said catheter for fluid circulation purposes and a return linefor returning heat transfer fluid to said fluid reservoir for fluidcirculation purposes, the method comprising: providing a fluidreservoir, the fluid reservoir comprising: a fluid reservoir body; anair-removal mechanism located in the body; an inlet line including anoutlet located within said body, said inlet line adapted to communicatewith said return line for returning fluid to said body duringcirculation; an outlet line including an inlet located at leastpartially within said body, said outlet line adapted to communicate withsaid supply line for supplying fluid to said catheter duringcirculation; and wherein the outlet of the inlet line is located closerto said air-removal mechanism than the inlet of said outlet line;circulating heat transfer fluid from said catheter through said returnline, into said inlet line, through said fluid reservoir body, out saidoutlet line, and through said supply line to said catheter; removing airfrom the circulation set with said air-removal mechanism.
 43. The methodof claim 42, wherein the outlet of said return line is located adjacentto said air-removal mechanism.
 44. A temperature and pressure sensorassembly of a circulation set of a heat transfer catheter for measuringtemperature and pressure of a heat transfer fluid flowing through asupply line for supplying heat transfer fluid to a catheter for fluidcirculation purposes and a return line for returning heat transfer fluidfrom said catheter for fluid circulation purposes, the temperature andpressure sensor assembly comprising: a multi-use, non-disposabletemperature and pressure sensor electronics member; a single-use,disposable temperature and pressure sensor block member removablycoupled to said electronics member so that said block member may bediscarded after a single use and said electronics member may be usedmultiple times with different disposable block assemblies, said blockmember adapted to communicate with said supply line and return line. 45.The assembly of claim 44, wherein said single-use, disposabletemperature and pressure sensor block member includes a block made ofpolycarbonate.
 46. The assembly of claim 44, wherein said single-use,disposable temperature and pressure sensor block member includes apressure sensor hole in communication with said supply lumen and adaptedto receive a pressure sensor of said electronics member, a temperaturesensor hole in communication with said supply lumen and adapted toreceive a temperature sensor of said electronics member, a pressuresensor hole in communication with said return lumen and adapted toreceive a pressure sensor of said electronics member, and a temperaturesensor hole in communication with said return lumen and adapted toreceive a temperature sensor of said electronics member.
 47. Theassembly of claim 44, wherein said electronics member includes apressure sensor adapted to be operatively associated with said supplylumen for measuring the pressure of said heat transfer fluid enteringsaid catheter, a temperature sensor adapted to be operatively associatedwith said supply lumen for measuring the temperature of said heattransfer fluid entering said catheter, a pressure sensor adapted to beoperatively associated with said return lumen for measuring the pressureof said heat transfer fluid exiting said catheter, and a temperaturesensor adapted to be operatively associated with said return lumen formeasuring the temperature of said heat transfer fluid exiting saidcatheter.
 48. The assembly of claim 47, further including a single-use,disposable temperature sensor coupler adapted to be received by saidtemperature sensor and communicate with said heat transfer fluid viasaid temperature sensor holes, said coupler made of a material having ahigh thermal conductivity so that said temperature sensor accuratelysenses the temperature of said heat transfer fluid without contactingsaid heat transfer fluid.
 49. The assembly of claim 47, furtherincluding a single-use, disposable pressure sensor membrane disposed insaid pressure sensor hole and adapted to be operatively associated withsaid pressure sensor and communicate with said heat transfer fluid tosense the pressure of said heat transfer fluid without contacting it.50. A single-use, disposable temperature and pressure sensor blockmember of a temperature and pressure sensor assembly of a circulationset of a heat transfer catheter for measuring temperature and pressureof a heat transfer fluid flowing through a supply line for supplyingheat transfer fluid to a catheter for fluid circulation purposes and areturn line for returning heat transfer fluid from said catheter forfluid circulation purposes, the temperature and pressure sensor blockmember comprising: a single-use, disposable temperature and pressuresensor block member adapted to be removably coupled to a multi-use,non-disposable temperature and pressure sensor electronics member sothat said block member may be discarded after a single use and saidelectronics member may be used multiple times with different disposableblock assemblies, said block member including a pressure sensor holeadapted to communicate with a supply lumen and receive a pressure sensorof said electronics member, a temperature sensor hole adapted tocommunicate with said supply lumen and receive a temperature sensor ofsaid electronics member, a pressure sensor hole adapted to communicatewith a return lumen and receive a pressure sensor of said electronicsmember, and a temperature sensor hole adapted to communicate with saidreturn lumen and receive a temperature sensor of said electronicsmember.
 51. The block member of claim 50, wherein said single-use,disposable temperature and pressure sensor block member includes a blockmade of polycarbonate.
 52. The block member of claim 50, furtherincluding a single-use, disposable temperature sensor coupler adapted tobe received by said temperature sensor and communicate with said heattransfer fluid via said temperature sensor hole, said coupler made of amaterial having a high thermal conductivity so that said temperaturesensor accurately senses the temperature of said heat transfer fluidwithout contacting said heat transfer fluid.
 53. The block member ofclaim 50, further including a single-use, disposable pressure sensormembrane disposed in said pressure sensor hole and adapted to beoperatively associated with said pressure sensor and communicate withsaid heat transfer fluid to sense the pressure of said heat transferfluid without contacting it.
 54. A method of using a single-use,disposable temperature and pressure sensor block member of a temperatureand pressure sensor assembly of a circulation set for a heat transfercatheter, the method comprising: removably attaching a single-use,disposable temperature and pressure sensor block member of a temperatureand pressure sensor assembly to a multi-use, non-disposable temperatureand pressure sensor electronics member; coupling said single-use,disposable temperature and pressure sensor block member to said heattransfer catheter; circulating heat transfer fluid through said blockmember and heat transfer catheter; sensing temperature and pressure ofheat transfer fluid flowing through said block member; disposing saidblock member but not said electronics member after a single use of saidheat transfer catheter.
 55. A method of using a single-use, disposabletemperature and pressure sensor block member of a temperature andpressure sensor assembly of a circulation set for a heat transfercatheter, the method comprising: removably attaching a single-use,disposable temperature and pressure sensor block member of a temperatureand pressure sensor assembly to a multi-use, non-disposable temperatureand pressure sensor electronics member, said block member including asupply lumen adapted to be coupled to said heat transfer catheter fordelivery of heat transfer fluid thereto, a return lumen adapted to becoupled to said heat transfer catheter for delivery of heat transferfluid therefrom, a pressure sensor hole adapted to communicate with saidsupply lumen and receive a sensor of said electronics member, atemperature sensor hole adapted to communicate with said supply lumenand receive a temperature sensor of said electronics member, a pressuresensor hole adapted to communicate with said return lumen and receive apressure sensor of said electronics member, and a temperature sensorhole adapted to communicate with said return lumen and receive atemperature sensor of said electronics member; coupling the supply lumenand return lumen of said block member with said heat transfer catheter;circulating heat transfer fluid through said supply lumen of said blockmember, heat transfer catheter, and return lumen of said block member;sensing temperature and pressure of heat transfer fluid flowing throughsaid supply lumen of said block member with said temperature andpressure sensors of said electronics member and sensing temperature andpressure of heat transfer fluid flowing through said return lumen ofsaid block member with said temperature and pressure sensors of saidelectronics member; disposing said block member but not said electronicsmember after a single use of said heat transfer catheter.
 56. The methodof claim 55, wherein said single-use, disposable temperature andpressure sensor block member includes a block made of polycarbonate. 57.The method of claim 55, further including a single-use, disposabletemperature sensor coupler adapted to be received by said temperaturesensor and communicate with said heat transfer fluid via saidtemperature sensor hole, said coupler made of a material having a highthermal conductivity so that said temperature sensor accurately sensesthe temperature of said heat transfer fluid without contacting said heattransfer fluid.
 58. The method of claim 55, further including asingle-use, disposable pressure sensor membrane disposed in saidpressure sensor hole and adapted to be operatively associated with saidpressure sensor and communicate with said heat transfer fluid to sensethe pressure of said heat transfer fluid without contacting it.
 59. Amethod of using a heat exchanger member in a circulation set for a heattransfer catheter, the circulation set including a heat exchangeradapted to transfer heat between the heat exchanger and heat transferfluid within the heat exchanger member for temperature control of theheat transfer fluid, the method comprising: providing a single-use,disposable heat exchanger member with said heat exchanger, said heatexchanger member including at least one passage adapted to allow heattransfer fluid to flow therethrough; transferring heat between said heatexchanger and said heat transfer fluid in said heat exchanger member,either to said heat transfer fluid from said heat exchanger or from saidheat transfer fluid to said heat exchanger; disposing said heatexchanger member, but not said heat exchanger after a single use of saidheat transfer catheter.
 60. The method of claim 59, wherein said heatexchanger member is adapted to be used with a dry heat exchanger so thatan outer surface of said heat exchanger member does not contact a heattransfer liquid.
 61. The method of claim 59, wherein said heat exchangermember is an IV bag adapted to be removably disposed between a pair ofheat exchanger molds.
 62. The method of claim 61, wherein said IV bag isadapted to be shaped into a serpentine heat transfer fluid path by apair of heat exchanger molds, and said step of providing said heatexchanger member with said heat exchanger includes providing said heatexchanger member between said pair of heat exchanger molds and moldingsaid IV bag so as to include a serpentine heat transfer fluid path. 63.A method of using a heat exchanger member in a circulation set for aheat transfer catheter, the circulation set including a heat exchangeradapted to transfer heat between the heat exchanger and heat transferfluid within the heat exchanger member for temperature control of theheat transfer fluid, the method comprising: providing a single-use,disposable IV or intravenous bag normally used for the intravenousdelivery of one or more fluids to the vasculature of a patient as a heatexchanger member with said heat exchanger, said IV bag including atleast one passage adapted to allow heat transfer fluid to flowtherethrough; transferring heat between said heat exchanger and saidheat transfer fluid in said IV bag, either to said heat transfer fluidfrom said heat exchanger or from said heat transfer fluid to said heatexchanger; disposing said IV bag but not said heat exchanger after asingle use of said heat transfer catheter.
 64. A heat exchanger of acirculation set for a heat transfer catheter, comprising: a pair of heatexchanger mold members each including an insulative body with an innersurface, a heat conductive face bonded to the inner surface of saidface, and one or more heat transfer liquid paths located between saidinner surface of said insulative body and said heat conductive face, theheat conductive face including a mold configuration and adapted, whenplaced together with the opposite face, to receive a disposable heatexchanger member and shape said disposable heat exchanger member intoone or more heat transfer paths for transferring a heat transfer fluidtherethrough.
 65. The heat exchanger of claim 64, wherein said heatconductive faces are adapted to isolate said heat transfer liquid froman outer surface of said heat exchanger member.
 66. The heat exchangerof claim 64, wherein said heat conductive faces are adapted to receivean IV bag and shape said IV bag into one or more heat transfer paths.67. The heat exchanger of claim 66, wherein said heat conductive facesare adapted to shape said IV bag into a serpentine heat transfer fluidpath.
 68. A method of identifying a heat transfer catheter or heattransfer element of a heat transfer catheter, comprising: measuringcatheter pressure at a variety of heat transfer fluid flow rates;determining a slope of a best fit line through a variety of data pointsdetermined by said measuring step; identifying the heat transfercatheter or heat transfer element by comparing the slope determined bysaid determining step to established slopes for a variety of differentheat transfer catheters or heat transfer elements.
 69. The method ofclaim 68, further including controlling one or more operationalparameters of the catheter or heat transfer element based on the heattransfer catheter or heat transfer element identified.